Percentage of patients that have not progressed [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.

Percentage of patients that have not progressed [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.

Percentage of patients that have not progressed [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.

Confirmed tumor response defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Ninety-five percent confidence intervals for the true proportion will be calculated using the exact binomial method.

Time to progression and death [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Estimated using Kaplan-Meier. Frequency distributions of baseline patient characteristics will be compared using chi-squared and Wilcoxon tests.

Original Secondary Outcome Measures ICMJE

Not Provided

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

Official Title ICMJE

A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme

Brief Summary

Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description

OBJECTIVES:

I. Determine the efficacy of CCI-779, in terms of the percentage of patients who are progression-free at 6 months, time to progression, and time to death, in patients with recurrent glioblastoma multiforme.

II. Determine the toxic effects of this drug in these patients. III. Correlate molecular alterations in the tumors of these patients with response to treatment with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to concurrent P450 anticonvulsant use (yes vs no).

Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 39 months.